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L-arginine Effects on Chronic Hypertension in Pregnancy

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ClinicalTrials.gov Identifier: NCT00974714
Recruitment Status : Completed
First Posted : September 10, 2009
Last Update Posted : January 20, 2010
Sponsor:
Collaborator:
Information provided by:

September 9, 2009
September 10, 2009
January 20, 2010
September 2007
June 2009   (Final data collection date for primary outcome measure)
to evaluate blood pressure changes during oral L-arginine or placebo administration in pregnant women with chronic hypertension at second trimester of gestation [ Time Frame: 14 weeks ]
Same as current
Complete list of historical versions of study NCT00974714 on ClinicalTrials.gov Archive Site
evaluate if is necessary to add a conventional therapy for hypertension, to evaluate pregnancy outcomes and eventual complications, to evaluate safety of oral L-arginine administration [ Time Frame: 14 weeks ]
Same as current
Not Provided
Not Provided
 
L-arginine Effects on Chronic Hypertension in Pregnancy
Effects of Oral L-arginine on Chronic Hypertension in Pregnancy
The purpose of this study is to evaluate the effects of oral L-arginine administration on pregnant women at second trimester of gestation with chronic hypertension, respect with placebo.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Hypertension in Pregnancy
  • Drug: L-arginine
    Oral L-arginine 2 g twice a day for 14 weeks
  • Other: placebo
    oral placebo 2 g twice a day for 14 weeks
  • Experimental: 1
    Oral L-arginine 2 g twice a day, for 14 weeks
    Intervention: Drug: L-arginine
  • Placebo Comparator: 2
    oral placebo twice a day for 14 weeks
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2009
June 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant women between 18-20 weeks of gestation with chronic hypertension

Exclusion Criteria:

  • Other maternal or fetal systemic disease
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00974714
Facchinetti
Neri Isabella ( Other Grant/Funding Number: Fabio Facchinetti )
De Pace Viviana ( Other Grant/Funding Number: Fabio Facchinetti )
Monari Francesca ( Other Grant/Funding Number: Fabio Facchinetti )
Dante Giulia ( Other Grant/Funding Number: Fabio Facchinetti )
Yes
Not Provided
Not Provided
Facchinetti Fabio, University of Modena and Reggio Emilia
University of Modena and Reggio Emilia
University of Modena
Not Provided
University of Modena and Reggio Emilia
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP